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FWD: Book Announcement for _Medical Writing in Drug Development_
Subject:FWD: Book Announcement for _Medical Writing in Drug Development_ From:"Eric J. Ray" <ejray -at- RAYCOMM -dot- COM> Date:Mon, 15 Jun 1998 11:37:08 -0600
Forwarded on request -- given the recent and recurring
discussions about "isn't anyone on this list writing about
anything besides software", it seems appropriate.
Eric
<FORWARDED>
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NEW BOOK JUST PUBLISHED from The Haworth Press!
http://www.haworthpressinc.com
e-mail: getinfo -at- haworthpressinc -dot- com
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Use this practical guidebook to help you tackle the challeges that
medical writing presents!
Medical Writing in Drug Development:
A Practical Guide for Pharmaceutical Research
Robert J. Bonk, PhD
Adjunct Assistant Professor, Philadelphia College of Pharmacy and
Science, University of Delaware
A guide through the maze of the pharmaceutical research and
development process, Medical Writing in Drug Development fills a gap
in the libraries of technical writers, college instructors, and
corporate professionals associated with the pharmaceutical process.
As it discusses critical information, such as strategies and
techniques pivotal to crafting documents for drug development, it
also overviews drug research, document types, the roles of
professional writers, and information technology. In no time at all,
you will be creating persuasive technical documents, building complex
facts into coherent messages, and contributing to the effective
marketing of new products with promotional pieces that meet legal
and ethical standards.
Contents
List of Figures List of Tables Foreword Preface
Acknowledgments PART I: MEDICAL WRITING FOR PHARMACEUTICAL RESEARCH
Chapter 1. Basic Introduction to Medical Writing Historical Roots
of Healthcare Communication Social Fabric of Medical Writing
Pharmaceutical Writing at the Forefront Chapter 2. Overview of Drug
Development Regulation of the Drug Process Sequence of Drug
Development Pharmacological Testing and Nonclinical Research
Filing the Investigational New Drug Application Protocols for
Clinical Trials First Three Phases of Clinical Research Overview
of a New Drug Application Fourth Phase of Clinical Research
Chapter 3. Types of Pharmaceutical Documents Analysis of Document
Audiences Regulatory Documents for Drug Submissions Publication
Documents for the Medical Community Rhetorical Strategies for
Pharmaceutical Documents Chapter 4. Professional Roles of Medical
Writers Structure of Medical-Writing Groups Background, Skills,
and Education Team Approach to Medical Writing Chapter 5.
Publishing and Information Technology Electronic Publishing of
Regulatory Documents Computerized Support for Publication Documents
Future Implications of Information Technology PART II: REGULATORY
DOCUMENTS FOR DRUG SUBMISSIONS Chapter 6. Structure of Regulatory
Submissions Pyramidal Structure of Regulatory Submissions Team
Interactions for the Medical Writer Chapter 7. Foundation Reports
of Research Trials Guidelines for Research Reports Clinical Trial
Report as an Example Rhetorical Strategy of Research Reports
Comparisons with Related Documents Chapter 8. Overview and Summary
Documents Overall Goals of Document Integration Rhetorical
Approaches for Summary Documents Typical Examples as Document
Models Chapter 9. Supportive Materials for Submissions Narrative
Documents for Administrative Support Tabular Summaries That Compile
Information Investigator's Brochure for Clinical Research Chapter
10. Dossiers for International Projects Acceleration of Drug
Development Regulatory Submissions as an Emergent Dossier Medical
Writers and the Emergent Dossier PART III: PUBLICATION DOCUMENTS
FOR THE MEDICAL COMMUNITY Chapter 11. Rhetorical Strategy for
Publications Types of Publication Documents Hooking the External
Audience Authorship and Ethical Issues Chapter 12. Manuscripts in
Scientific Journals Key Aspects of Manuscript Preparation
Alternative Formats for Journal Submissions Ethical Issues for
Journal Manuscripts Chapter 13. Materials for Professional Meetings
Abstracts Submitted for Acceptance Slides and Posters for
Presentation Proceedings of the Overall Conference Ethical
concerns of Redundant Publication Chapter 14. Promotional Pieces
for Marketing Promotion Within the Marketing Mix Supportive
Documents for Drug Promotion Ethical and Legal Constraints on
Promotion Chapter 15. Challenges of Broadening Audiences New
Topics and New Media for New Audiences Ethical Responsibility for
the Profession APPENDIXES: TEMPLATES FOR MEDICAL-WRITING DOCUMENTS
Appendix A. Template for a Clinical Trial Report Appendix B.
Template for an Overview Regulatory Document Appendix C. Template
for a Publication Manuscript References Index
"COMPREHENSIVE AND EXCEPTIONALLY WELL-ORGANIZED, Bonk's book will
serve as an outstanding resource for practitioners and students
alike. The range of coverage is impressive-from regulatory writing
and audience analysis to the rhetorical strategy for publications and
the ethical responsibilities of biomedical writers. . . . The
templates for clinical trial reports, an overview of regulatory
documents, and a publication manuscript should prove to be valuable
to all professionals."
-- William T. Walker, PhD, Associate Dean, Arts and Sciences, and
Chair, Department of Humanities, Philadelphia College of Pharmacy and
Science
"Offers students a helpful introduction to pharmaceutical writing. It
can also be of use to others wishing to explore this field. The
appendixes and some of the tables are especially helpful. . . . Helps
fill an important niche. It is a welcome addition to my medical
writing bookshelf."
-- Barbara Gastel, MD, Associate Professor of Journalism and Medical
Humanities and Coordinator, MS Program in Science and Technology
Journalism, Texas A & M University
"For medical writers new to the profession, this book is a valuable
and practical guide. Skilled medical writers will recognize that the
author has a wealth of professional experience. . . . Offers medical
writers sound, practical advice and guidance on present-day and
future challenges to the profession."
-- Jane Mitchell, DPhil, Medical Writing Services, UK
